Predicting change of tear layer thickness under scleral contact lenes in keratoconus patients and compare with normal volunteers: A pilot study

Recruiting

• Conditions: Predicting change of tear layer thickness under scleral contact lens in keratoconus patients and compare with normal volunteers; Predicting change, tear layer thickness, scleral contact lens, keratoconus

• Registration Number: TCTR20221208004
• Lead Sponsor: Faculty of Medicine Siriraj Hospital, Mahidol University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-08
• Study Completion: 2023-12-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Keratoconus patients, who have been diagnosed with keratoconus and use scleral contact lenses at least 4-6 hours a day.
2. Control groups, healthy volunteers without any corneal disease (over 18 years old).
3. Age > 12 years old.
* Because there are few keratoconus patients treated with scleral contact lens and some are pediatric patients under the age of 18.

Exclusion Criteria

1. have an infection of the eyelids, conjunctiva, cornea or eyeball on the day of study.
2. have used any eye drops during the eye exam.
3. who are contraindicated in using contact lens.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change rate of tear layer thickness at 0 min, 30 min, 1 hour, 2 hour, 3 hour, 4 hour, 6 hour Change of tear layer thickness under scleral contact lens at different time

Secondary Outcome Measures

Name	Time	Method
Compare change rate of tear layer thickness at 0 min, 30 min, 1 hour, 2 hour, 3 hour, 4 hour, 6 hour Change of tear layer thickness under scleral contact lens in keratoconus patients and compare with normal volunteers at different time